Fern F H, Bartell L
Health Matrix. 1987 Fall;5(3):17-23.
The Federal Drug Administration (FDA) has developed comprehensive procedural and substantive regulations to control the format of and information contained within package inserts distributed by pharmaceuticals. FDA regulations should be pervasive and preempt any state action on pharmaceutical labeling. However, courts have recently allowed jurors to reevaluate specific FDA scientific judgements in the context of product liability actions. This article discusses the Federal Preemption Doctrine as it relates to the regulation of package insert labeling by both the FDA and the state. First, the examination begins with background information on the Preemption Doctrine and the statutory authority of the FDA, followed by a discussion with a review of case law on the subject.
美国食品药品监督管理局（FDA）已制定了全面的程序和实体法规，以控制药品所附说明书的格式及其中包含的信息。FDA的法规应具有普遍性，并优先于各州对药品标签采取的任何行动。然而，法院最近允许陪审员在产品责任诉讼的背景下重新评估FDA的特定科学判断。本文讨论联邦优先原则，该原则涉及FDA和各州对说明书标签的监管。首先，考察从优先原则的背景信息和FDA的法定权限开始，随后是对有关该主题的判例法的讨论和回顾。
